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Health See other Health Articles Title: Parachute membrane improves damaged heart Parachute Reshapes Post-MI Ventricle, Ups LVEF at One Year Medscape ATHENS, GREECE — The percutaneous Parachute (CardioKinetix) fits like an upside-down umbrella within the apex of the left ventricle, apparently helping to reduce wall stresses that have distorted the myocardium's shape, hurting pumping efficiency. Early experience suggests that it can improve measures of cardiac structure, symptoms, and exercise capacity over a year following implantation in patients with prior anteroapical MI. There are also signs that its benefits might extend to improved survival and a lower risk of hospitalizations, although no controlled trial has been completed. A pooled analysis of the first 111 patients treated with the device and followed with echocardiography, a combination of four separate cohorts, showed significant improvements in left-ventricular end-systolic and end-diastolic volume indexes (LVESVi and LVEDVi, respectively) and even left-atrial volume index. The latter is evidence that the device's salutary effects on apical regional wall-motion abnormalities can improve remodeling indexes more globally, according to Dr William Abraham (Ohio State University, Columbus), who presented the analysis here at the Heart Failure Congress 2014 of the European Society of Cardiology Heart Failure Association. All patients had post-MI heart failure with anteroapical wall motion abnormalities; 60% had been in NYHA class 3 heart failure at baseline, the rest had been in class 2. About one-third had been hospitalized for heart failure within the previous 12 months. Such patients, Abraham said, would be expected to have high 12-month rates of mortality and heart-failure hospitalization. The implantation success rate was 95.5%; total procedure and fluoroscopy time averaged 86 and 21 minutes, respectively. Hospitalization time averaged 2.9 days in the US and 5.9 days in Europe. The rate of bleeding or other major procedural complications averaged 7.2%, Abraham said. By 12 months, there were significant reductions in LVES and LVED volumes and a significant but modest rise in LVEF; left-atrial volume index also improved significantly. Echocardiographic Improvements at 12 Months in 111 Patients Implanted With the Parachute End point Baseline 12 months p LVESVi, mL/m2 87.6 73.2 <0.0001 LVEDVi, mL/m2 120.8 103.8 <0.0001 LVEF, % 28.4 30.4 <0.05 Contractility index, mmHg-m2/mL 18.5 20.3 <0.0001 LA volume index, mL/m2 43.6 37.8 <0.05 LVEDVi=left-ventricular end-diastolic volume index LVESVi=left-ventricular end-systolic volume index Six-minute walk distance lengthened by 25 m (p<0.05) from baseline to 12 months; among patients who improved >20 m, the mean was 87 m. There were also apparent benefits in NYHA functional class: NYHA class improved in 54% of patients and was maintained in 32%. Of those in class 2 at baseline, 51% improved to class 1 and 32% stayed in class 2. Of those in class 3 at baseline, 40% improved to class 2 and another 16% went from severe heart failure to asymptomatic by ending the year in class 1; 29% stayed in class 3. Clinical outcomes at 12 months compared favorably to the literature for similar patients, according to Abraham. The cohort's all-cause mortality was 5.7% and rate of death/heart-failure hospitalization was 21.7%; the stroke rate was 2.9%. As discussant for the Parachute presentation, Dr Veselin Mitrovic (Kerckhoff-Klinik, Herz- und Thoraxzentrum, Bad Nauheim, Germany) said the device represents a percutaneous incarnation of ventricular reduction surgery for which results have been mixed. So far, however, hemodynamic outcomes and effects on exercise tolerance and symptoms with the Parachute seem favorable. Especially important in the current analysis is the improvement in LVES volume, which has been shown to be a major prognostic predictor following acute MI, according to Mitrovic. Still, all the observed LV volume changes were "expected results," he said. "More important would be the effect on late LV remodeling and whether these changes are sustained for longer follow-up periods, and their effects on long-term morbidity and mortality." Whether the device interferes with papillary muscles or apical chordae tendineae is unknown, as are the risks and consequences of dislocation. But "preliminary results are encouraging, and further prospective randomized studies with longer follow-ups are needed." Abraham is coprincipal investigator of just such a trial in the US, called PARACHUTE IV . Ongoing with a planned completion for the primary outcome in 2016, the trial has a projected enrollment of 560 post-MI patients. Entry criteria include ischemic NYHA class 3 or ambulatory class 4 heart failure with LV wall-motion abnormalities and an LVEF <35%. Abraham discloses receiving consulting fees or honoraria from CardioKinetix within past 12 months. Mitrovic had no disclosures. Post Comment Private Reply Ignore Thread
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